Epilepsy Guidelines in the Real World: The Sound of Music?

“The hills are alive with the sound of music” Richard Rodgers and Oscar Hammerstein II, 1959 Type “epilepsy guidelines” into the Google search engine, and you will access 202 entries from across the globe in a number of languages. Many are aimed at the medical and allied professions and others are written for people with epilepsy and their families and caregivers. Topics range from epidemiology, diagnosis, investigation, and management to specialist issues such as pregnancy, cognition, surgery, and drug formulations. How much of this is music, and how much is just noise? Guidelines are increasingly influencing everyday clinical practice from decisions made in the operating theater to prescribing in primary care. They can be defined as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” (1). Factors such as the spiralling cost of medical care, aging populations, higher patient expectations, increasing media awareness, and local variations in health services have been fundamental to their production (2). They are perceived internationally as a way of improving health care outcomes while curbing unnecessary expense (3). Hospital specialists, family doctors, and patient advocates should all be involved in the development process. Flexibility, brevity, and ownership appear to be the keys to ensuring their success (4). The medicolegal implications of the widespread adoption of clinical guidelines also must be taken into consideration. Although doctors are not obliged to follow “approved” guidelines, it is generally recommended that they do so and that they record any deviation from them clearly in the patient's case sheet together with the reason for the deviation (5). In British courts, minimal acceptable standards of clinical care derive from responsible customary practice rather than from guideline recommendations (6). Thus the evidence of an expert witness continues to take precedence over guidelines. In the United States, guidelines are increasingly being used in malpractice litigation, by both plaintiff's and defendant's attorneys (7). They also appear to have an important role in the settlement of cases out of court. Although little is known about the extent of their use in this way, their influence can only increase with time. The Scottish Intercollegiate Guidelines Network (SIGN) was launched in 1993 by the Academy of the Scottish Royal Colleges and their faculties (8,9). Its aim was to develop evidence-based clinical guidelines for the National Health Service (NHS) in Scotland. In the past 10 years, more than 70 guidelines have been published on a wide variety of topics. Each was compiled by a collaboration of health care professionals, members of support services, and patient representatives. SIGN guidelines are based on findings from publications derived from systematic literature reviews. As part of the production process, they are discussed at open national meetings and appraised by independent expert referees. The pilot edition of number 21, Diagnosis and Management of Epilepsy in Adults, was published in 1997 (10). An updated version hit the streets in April 2003 (11). A separate document for pediatric practice is at an advanced stage of development. The ethos behind SIGN guideline implementation involves a standard clinical effectiveness cycle that “translates research into practice, sets and monitors standards, and promotes clinical excellence in the NHS in Scotland” (12). SIGN guidelines are disseminated to all general practitioners and hospital specialists, as well as being made available on the Internet (http://www.sign.ac.uk). It is at this point, however, that the evidence-based trail invariably goes cold. Are the guidelines being implemented with enthusiasm? Are they being implemented at all? If so, do they make a difference to clinical practice? Do they improve the lives of patients? To investigate this, Julian Davis and his colleagues (13) attempted to assess the impact of SIGN guideline number 21 on outcomes in primary care. The authors targeted 68 general practices in Tayside, an area covering 3,000 square miles in the east of Scotland and encompassing a mix of urban and rural general practices. Each practice was randomized by computer to one of three interventions (“control,”“intermediate,” or “intensive”), all of which were designed to promote the dissemination of the guideline. “Control” consisted of postal distribution of SIGN guideline number 21. “Intermediate” intervention backed the document with interactive workshops and structured protocols. All of these were provided to the “intensive” practices, with the additional assistance of a nurse specialist to advise on the establishment of epilepsy review clinics. Davis and coworkers assessed the effect of these interventions on the quality of life of people with epilepsy in all the targeted practices. In addition, they monitored the number of patient reviews and counseling sessions undertaken in those practice randomized to the “intensive” arm of the study. The primary outcome measure was the SF-36 health-related quality-of-life profile. Secondary measures included a battery of prevalidated epilepsy-specific quality-of-life instruments. Uptake of the guidelines was generally poor, and no differences were found in health status scores among the patients of practices in the three arms of the study. Scores were, as expected, below those of a healthy population, consistent with other chronic disease states. No increase occurred in patient reviews or counseling sessions in the practices receiving “intensive” intervention. It must be recognized that local Scottish issues could make implementation of the SIGN epilepsy guidelines problematic, the most important of which is limited access to specialist epilepsy services. Two critical recommendations in guideline 21 are that “The diagnosis of epilepsy should be made by a neurologist or other epilepsy specialist” and “The decision to start antiepileptic drugs should be made by the patient and an epilepsy specialist.” In a country where only one neurologist is in practice for every 200,000 of the population, access to neurology services can take time, and some patients will wait months for a hospital appointment. Availability of magnetic resonance imaging and electroencephalography also is limited, with a shortage of equipment and technicians. It is little wonder, therefore, that some family doctors and general physicians feel the need to start antiepileptic drug (AED) treatment themselves, thereby fueling the high misdiagnosis rate in the United Kingdom (14). With some 70 SIGN guidelines now in circulation in Scotland, it is a tall order to expect family doctors to digest and implement all their recommendations at a local level. Objective, thorough guideline analysis requires protected time, which is not always easy to identify. Everyday stresses may be accompanied by an inertia fostered by years of “tried and tested” personal practices. Guideline “fatigue” also is a real entity. Many clinicians working in the hospital sector have adopted a subspecialist approach to part of their practice. Primary care physicians may be the last of a dying breed of generalists. Alternatively, perhaps they too should specialize? (15). Davis and colleagues are not alone in recognizing that guideline uptake can be disappointing in primary care (4). Why should this be the case when calls for improvement are issued daily by health care strategists? Change can be difficult to implement. It takes time and requires not only motivation but also the perception that an alteration in routine practice will be beneficial to patients. It requires the involvement of not just doctors, but also the whole multidisciplinary health care team, encouraged, perhaps, by a dollop of political pressure. The identification of lead clinicians to facilitate the process is fundamental to its success. Good liaison between community and hospital services also is essential. Change management is an integral part of modern business practice and could be applied with benefit to the health care industry. The current political enthusiasm for guidelines will undoubtedly affect increasing numbers of clinicians. A well-constructed document should produce improvements in local care and uniformity of health outcomes. Gaps in service provision and research should be identified. Heightened public awareness should lead to patient empowerment and should influence positively political decision making. Guidelines not only must be good but also must be shown to improve the lives of people with epilepsy. It is not enough to launch them with a fanfare and a round of backslapping. A focused plan for their implementation and robust assessment of their impact are essential accompaniments to their dissemination. Otherwise, as in Scotland, much noise but little music is heard.